Last updated on March 2019

Multinational Clinical Study Comparing Isatuximab Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients


Brief description of study

Primary Objective:

To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously treated with 1 to 3 lines of therapy.

Secondary Objectives:

  • To evaluate the Overall Response Rate (ORR), rate of very good partial response (VGPR) or better and complete response (CR) rate in both arms using International Myeloma Working Group (IMWG) criteria.
  • To evaluate rate of VGPR or better with minimal residual disease (MRD) negativity in both arms using IMWG criteria.
  • To evaluate the Overall Survival (OS) in both arms.
  • To evaluate safety in both arms.
  • To evaluate duration of response (DOR) in both arms.
  • To evaluate the Time To Progression (TTP) in both arms.
  • To evaluate the Second Progression Free Survival (PFS2) in both arms.
  • To determine the Pharmacokinetic profile of isatuximab in combination with carfilzomib.
  • To evaluate the immunogenicity of isatuximab in isatuximab arm.
  • To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status in both arms.

Detailed Study Description

The duration of the study for the patients will include a period for screening of up to 3 weeks. Patients will continue study treatment until disease progression, unacceptable adverse reaction, patients' wish or other reason of discontinuation. During follow-up, patients who discontinue the study treatment due to progression of the disease will be followed every 3 months (12 weeks) for further anti-myeloma therapies, progression free survival to the second progression and survival, until death or the cut-off date, whichever comes first. Patients who discontinue the study treatment prior to documentation of disease progression will be followed-up every 4 weeks until confirmation of disease progression, and then every 3 months (12 weeks) for further anti-myeloma therapies, progression free survival to the second progression and survival, until death or the cut-off date, whichever comes first. After progression free survival analysis, patients will be followed yearly for 3 years for survival.

Clinical Study Identifier: NCT03275285

Contact Investigators or Research Sites near you

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Trial Transparency email recommended (Toll ...

Investigational Site Number 0360004
Heidelberg West, Australia
2.13miles
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Trial Transparency email recommended (Toll ...

Investigational Site Number 0360001
Fitzroy, Australia
4.05miles
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Recruitment Status: Open


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